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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K250443

MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile · Siemens Healthcare GmbH · decided 2025-06-16 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
MAGNETOM Viato.Mobile11689652Siemens Healthcare GmbHLNH LNI MOS04056869985558
MAGNETOM Skyra Fit11516217Siemens Healthcare GmbHLNH LNI MOS04056869299273
MAGNETOM Avanto Fit11516216Siemens Healthcare GmbHLNH LNI MOS04056869299266